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Posted On: 12/04/2020 12:54:46 AM
Post# of 148936
FDA looking more like an embarrassment to the whole world. How will they look when another country approves leronlimab first? India rejects EUA request for Lilly's Bamlanivimab, which was already granted by US FDA.
https://theprint.in/health/modi-govt-expert-p...ug/556481/
“While the safety and effectiveness of this investigational therapy continues to be evaluated, Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the US FDA said while announcing the EUA.
However, in India, the Subject Expert Committee (SEC) that advises the apex regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials has rejected the proposal that also asked for “waiver of the local clinical trials”.
https://theprint.in/health/modi-govt-expert-p...ug/556481/
“While the safety and effectiveness of this investigational therapy continues to be evaluated, Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the US FDA said while announcing the EUA.
However, in India, the Subject Expert Committee (SEC) that advises the apex regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials has rejected the proposal that also asked for “waiver of the local clinical trials”.
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